MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G50338

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 03/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during an angioplasty, an advance 14 lp low profile balloon catheter balloon tip separated from the catheter while inside the patient.The user attempted, unsuccessfully, to remove the separated portion of the device.The separated portion was then stented to the wall of the superficial femoral artery.The patient's anatomy was reportedly calcified.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information regarding event details has been requested, but is not available at this time.

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information was received 15apr2020.The device separated after percutaneous transluminal angioplasty of a 75% occluded lesion in the mid-superficial femoral artery.A cook 6 french ansel sheath was used during the procedure.An unknown inflation device was used to inflate the balloon to nominal pressure twice, for one minute each time, using a 50/50 solution of omnipaque contrast.The balloon was not removed from the body between inflations.The balloon was removed by itself, as the user reportedly encountered more tension when attempting to remove it through the sheath.The anatomy was not reported to be tortuous; however, some calcification was present.Blood was not noted in the inflation device.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: c.Description of event: as reported, during an angioplasty, an advance 14 lp low profile balloon catheter balloon tip separated from the catheter while inside the patient.The user attempted, unsuccessfully, to remove the separated portion of the device.The separated portion was then stented to the wall of the superficial femoral artery.The patient's anatomy was reportedly calcified.Additional information was received 15apr2020.The device separated after percutaneous transluminal angioplasty of a 75% occluded lesion in the mid-superficial femoral artery.A cook 6 french ansel sheath was used during the procedure.An unknown inflation device was used to inflate the balloon to nominal pressure twice, for one minute each time, using a 50/50 solution of omnipaque contrast.The balloon was not removed from the body between inflations.The balloon was removed by itself, as the user reportedly encountered more tension when attempting to remove it through the sheath.The anatomy was not reported to be tortuous; however, some calcification was present.Blood was not noted in the inflation device.Investigation ¿ evaluation : a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.One device was returned for investigation.The complainant returned one used ptax4-14-170-4-12 to cook for investigation.Biomatter was present on the returned complaint device.Physical examination of the returned device confirmed that the catheter distal tip separated from the balloon catheter.The separated distal tip was not returned with the complaint device.Additionally, the balloon was ruptured circumferentially.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: device description : ¿the balloon is manufactured from an extra-thinwall, high-strength, minimally compliant material.Particular care should be taken in handling the balloon to prevent damage.It will inflate to the indicated size parameters when utilizing proper pressure recommendations.Adhere to balloon inflation pressure parameters indicated in the compliance card insert.Refer to label for further information.Use of a pressure gauge is recommended to monitor inflation pressures.¿ intended use : "the advance 14lp low profile pta balloon dilatation catheter is intended for percutaneous transluminal angioplasty (pta) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae." warnings : ¿do not exceed rated burst pressure.1 rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.¿ ¿do not use a power injector for balloon inflation.Rupture may occur.¿ instructions for use : balloon preparation : "choose a balloon appropriate to lesion length and vessel diameter." ¿upon removal from package, inspect catheter to ensure no damage has occurred during shipping.¿ balloon introduction and inflation : "note: if resistance is encountered while advancing the balloon dilatation catheter, determine the cause and proceed with caution." "inflate balloon to desired pressure.Adhere to recommended balloon inflation pressures.(see compliance card insert.)" "if balloon pressure is lost and / or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit." how supplied : ¿store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded that a definitive conclusion could not be determined.However, separation of the balloon catheter distal tip most likely occurred as a result of the balloon rupturing circumferentially.The information provided upon review of complaint file, device history record, complaint history, device master record, and design validation testing provide objective evidence to support that the device was manufactured to specification.The complaint was confirmed based on investigation of the returned device.The risk analysis for this failure mode was updated in response to this incident.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No new patient or event information to report.

• Brand Name: ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9933177
• MDR Text Key: 186722973
• Report Number: 1820334-2020-00776
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002503387
• UDI-Public: (01)10827002503387(17)211130(10)9346651
• Combination Product (y/n): N
• PMA/PMN Number: K170193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: G50338
• Device Catalogue Number: PTAX4-14-170-4-12
• Device Lot Number: 9346651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Manufacturer Received: 03/27/2020
• Initial Date FDA Received: 04/07/2020
• Supplement Dates Manufacturer Received: 04/15/2020; 10/15/2020
• Supplement Dates FDA Received: 04/20/2020; 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention